SUBJECT:

The Residence at Salem Woods

Petitioner,

Centers for Medicare & Medicaid Services.

DECISION

Petitioner, The Residence at Salem Woods, was not in substantial compliance with Medicare and Medicaid federal participation requirements for the period January 25, 2002 through March 15, 2002. A civil money penalty (CMP) of $250 per day for the 49-day period of noncompliance, a total CMP of $12,250, is reasonable.

I. PROCEDURAL HISTORY

Petitioner, located in Cincinnati, Ohio, is certified to participate in the Medicare program as a skilled nursing facility (SNF) and in the state Medicaid program as a nursing facility (NF). Petitioner filed a request for hearing dated May 6, 2002, challenging the findings of a standard survey of Petitioner's facility completed by the Ohio Department of Health (the state agency) on January 25, 2002. The state agency alleged, based upon the survey, that Petitioner was not in compliance with 13 federal program participation requirements.

Based on the recommendations of the state agency, the Centers for Medicare & Medicaid Services (CMS) proposed a CMP in the amount of $600 per day effective January 25, 2002, a mandatory denial of payment for new admissions (DPNA) effective April 25, 2002, and termination of Petitioner's provider agreement, effective July 25, 2002. CMS exhibit (CMS Ex.) 5.

Petitioner requested Informal Dispute Resolution (IDR). IDR resulted in three deficiencies (Tags F 166, F 242, and F 314) being deleted from the Statement of Deficiencies, Form 2567L (SOD). CMS Exs. 2, 3. On March 5, 2002, Petitioner requested Phase Two IDR regarding Tag F 324 only. CMS Ex. 2 at 6. Phase Two IDR resulted in no further deletions or changes to the SOD except for a dispute concerning Resident 79 which is discussed in the Analysis section (Part III.C.8.a.) of this decision. As a result of the deletion of three deficiencies from the first IDR, the CMP was reduced to $450 per day. CMS Ex. 9. It was determined on a revisit survey on March 27, 2002, that Petitioner achieved substantial compliance effective March 16, 2002, and the proposed mandatory DPNA and termination were rescinded. Id. CMS advised Petitioner that it was imposing a total CMP of $22,500 or $450 per day beginning on January 25, 2002 and continuing through March 15, 2002. Id. Petitioner requested a hearing on May 6, 2002, which stays collection of the CMP until completion of the hearings and appeals process.

This case was assigned to me for hearing and decision on May 24, 2002. A hearing took place on January 30, 2003 in Cincinnati, Ohio, the substance of which is recorded in the 300-page transcript (Tr.) of the proceedings. At the hearing, CMS submitted 23 exhibits, CMS exhibits (CMS Exs.) 1 - 11, 11A, 12 - 19, 19A, 20, and 21. Petitioner submitted 16 exhibits (P. Exs.) 1 - 16. I admitted as evidence CMS Exs. 1 - 11, 11A, 12 - 19, 19A, 20, 21 and P. Exs. 1 - 16.

Petitioner timely filed its post-hearing brief on May 9, 2003 (P. Brief). CMS filed its post-hearing brief on May 13, 2003, four days past the filling deadline (CMS Brief). For good cause shown and in the absence of an objection, I granted CMS's motion for filing out of time. Both parties timely filed post-hearing reply briefs on May 30, 2003 (CMS Reply and P. Reply).

II. FINDINGS OF FACT AND CONCLUSIONS OF LAW

A. FINDINGS OF FACT

The following findings of fact are based upon the exhibits admitted. Citations to exhibit numbers related to each finding of fact may be found in the Analysis section of this decision if not indicated here.

1. Petitioner is located in Cincinnati, Ohio and is certified to participate in the Medicare program as a SNF and in the state Medicaid program as a NF.

2. Petitioner requested a hearing by letter dated May 6, 2002, to challenge the findings of a standard survey of Petitioner's facility completed by the state agency on January 25, 2002, which resulted in a determination that Petitioner was not in substantial compliance.

3. It was determined on a revisit survey that Petitioner achieved substantial compliance effective March 16, 2002. CMS. Ex. 9.

4. Petitioner was cited with violations of 42 C.F.R. �� 483.10(f)(2) (Tag F 166); 483.15(b) (Tag F 242); 483.20(b)(2)(ii) (Tag F 274); 483.20(k)(2) (Tag F 280); 483.20(k)(3)(i) (Tag F 281); 483.25 (Tag F 309); 483.25(a) (Tag F 311); 483.25(a)(3) (Tag F 312); 483.25(c) (Tag F 314); 483.25(d)(2) (Tag F 316); 483.25(h)(2) (Tag F 324); and 483.75(f) (Tag F 498). The violation of section 483.25(h)(2) (Tag F 324) was alleged to present actual harm.

5. Petitioner participated in IDR, resulting in three deficiencies (Tag F 166, Tag F 242, and Tag F 314) being deleted from the SOD. CMS Exs. 2, 3.

6. After the IDR, CMS reduced the proposed CMP to $450 per day, a total CMP of $22,500 ($450 per day beginning on January 25, 2002 and continuing through March 15, 2002). CMS Ex. 9.

7. Facts related to Tag F 274:

a. A quarterly Minimum Data Set (MDS) was done for Resident 14 on September 6, 2001 and on November 1, 2001.

b. A quarterly MDS was done on Resident 41 on August 6, 2001 and on November 7, 2001.

c. A quarterly MDS was done on Resident 45 on September 9, 2001 and on November 28, 2001.

d. Petitioner had until January 28, 2002 to complete a comprehensive assessment on Resident 79.

8. Facts related to Tag F 280:

a. There was no plan of care concerning antibiotic resistant respiratory infection requiring isolation for Resident 30.

b. There was no plan of care concerning Resident 27's long-standing problem of resisting care from Petitioner's staff.

c. Petitioner did have a plan of care concerning the use of pressure reduction devices for Resident 27.

9. Facts related to Tag F 281:

a. Resident 68's consumption was not recorded every shift as required by physician's order.

b. Daily temperatures were not taken as required by physician's order.

10. Facts related to Tag F 309:

a. Resident 14 was observed by the surveyor without the physician-ordered protective stockings and gloves on.

b. Resident 14 was observed by the surveyor leaning forward with her face and chin into and on her food plate and with her head on her knees while Petitioner's staff failed to reposition Resident 14.

c. Resident 2 was observed by the surveyor without heel protectors, with heels directly on the mattress, and without being repositioned as care planned.

d. Physician orders required that Resident 35 keep both heels elevated but Resident 35 was observed by the surveyor with his right heel in contact with the mattress.

e. Resident 68 was observed by the surveyor without physician-ordered bilateral foot splints.

11. Fact related to Tag F 311: Resident 14 was able to participate only rarely in activities of daily living.

12. Facts related to Tag F 312:

a. Resident 2 was not repositioned every two hours as required by her care plan during a four-hour period of observation by the surveyor.

b. Resident 2 was not provided with incontinent care as required by her care plan during a four-hour period of observation by the surveyor.

c. Resident 26 was observed by the surveyor with dirty and greasy hair.

d. Resident 27 was observed by the surveyor in torn clothing for a period of more than six hours.\

e. Petitioner did not show it made any attempt to intervene with Resident 27's family to obtain appropriate clothing for Resident 27.

13. Facts related to Tag F 316:

a. Petitioner's staff did not offer or assist Resident 14 in toileting during a five-hour period of observation by the surveyor even though Resident 14's brief was changed twice

b. .etitioner's staff did not offer or assist Resident 27 in toileting during observations by the surveyor that took place over extended periods of time even though Resident 27's care plan provided for toileting in advance of need.

14. Facts related to Tag F 324:

a. The example concerning Resident 79 was deleted after the first phase of IDR.

b. After Phase Two of the IDR, the example related to Resident 79 was again included as an example cited as a violation of Tag F 324.

c. Petitioner admitted to getting a complete document exchange from CMS and discussed the issue of falls related to Resident 79 in its prehearing brief.

d. Resident 14 suffered from a history of falls, was assessed at risk for falls, and was classified as independent with supervision required for wheelchair mobility.

e. Petitioner permitted Resident 14 to go outside unsupervised and unattended.

f. On November 16, 2001, Resident 14 was found outside tipped over in her wheelchair.

g. As a result of the November 16, 2001 fall, Resident 14 fractured her right clavicle.

h. Resident 14's fall resulted in actual harm.

i. Resident 57 had a history of falls.

j. Resident 57's care plan included floor mats at the bedside.

k. The surveyor observed Resident 57 on two days in bed without floor mats at the bedside.

l. No potential for harm has been shown by CMS for the example of Resident 42.

15. Facts related to Tag F 498:

a. Nurse aides were observed by the surveyor transferring Resident 27 by lifting the resident under the axilla (arm pits) and without using a gait belt.

b. Resident 26 was observed by the surveyor with his legs and feet being dragged across the floor.

c. The surveyor observed Resident 45 being transferred to and from a wheelchair while the wheelchair was not in a locked position.

d. The surveyor observed Resident 78 being transferred to and from a geri-chair while the chair was not in a locked position.

e. Nurse aides were observed by the surveyor lifting Resident 14 under the right arm against physician's orders.

16. CMS determined to impose a CMP of $450 per day based upon the existence of nine deficiencies, one involving actual harm.

17. Petitioner has a history of prior violations. CMS Ex. 8.

18. There is no evidence of an inability to pay a CMP.

19. Tag F 324 was proved by two examples, not by four examples as alleged by CMS.

B. CONCLUSIONS OF LAW

1. Petitioner's request for hearing was timely, and I have jurisdiction.

2. CMS failed to make a prima facie showing that Petitioner was in violation of 42 C.F.R. � 483.20(b)(2)(ii) (Tag F 274).

3. Petitioner violated 42 C.F.R. � 483.20(k)(2) (Tag F 280) as it relates to both Residents 27 and 30.

4. Petitioner violated 42 C.F.R. � 483.20(k)(3)(i) (Tag F 281) as it related to Resident 68.

5. Petitioner violated 42 C.F.R. � 483.25 (Tag F 309) as it relates to Residents 2, 14, 35, and 68.

6. CMS has not made a prima facie showing of a violation of 42 C.F.R. � 483.25(a)(2) (Tag F 311) with regard to Resident 14.

7. Petitioner violated 42 C.F.R. � 483.25(a)(3) (Tag F 312) as it relates to Residents 2, 26 and 27.

8. Petitioner violated 42 C.F.R. � 483.25(d)(2) (Tag F 316) as it relates to Residents 14 and 27.

9. CMS has not shown that Petitioner had "reasonable notice" that the example concerning Resident 79 under Tag F 324 continued to be a basis for the proposed remedy in this case.

10. Petitioner violated 42 C.F.R. � 483.25(h) (Tag F 324) as it relates to Resident 14.

11. Petitioner violated 42 C.F.R. � 483.25(h) (Tag F 324) as it relates to Resident 57.

12. CMS did not make a prima facie showing of a violation of 42 C.F.R. � 483.25(h) (Tag F 324) with regard to Resident 42.

13. Resident 14 suffered actual harm due to the violation of 42 C.F.R. � 483.25(h) (Tag F 324).

14. Petitioner violated 42 C.F.R. � 483.75(f) (Tag F 498) as it relates to Residents 14, 26, 27, 45, and 78.

15. The CMP of $450 per day is not reasonable, and it is, therefore, reduced to $250 per day, which is reasonable given the factors specified at 42 C.F.R. � 488.438(f).

III. ANALYSIS

A. ISSUES

The issues in this case are:

Whether there is a basis for the imposition of an enforcement remedy; and,

Whether the remedy imposed is reasonable.

B. APPLICABLE LAW

Petitioner is a long-term care facility participating in both the Medicare program as a SNF and in Medicaid as a NF. The statutory and regulatory requirements for participation by a long-term care facility are found at sections 1819 and 1919 of the Social Security Act (Act), and at 42 C.F.R. Part 483. ⁽¹⁾ Sections 1819 and 1919 of the Act give the Secretary of Health and Human Services (the Secretary) authority to impose a CMP against a long-term care facility for failure to comply substantially with federal participation requirements.

Pursuant to the Act, the Secretary has delegated to CMS and the states the authority to impose remedies against a long-term care facility that is not complying substantially with federal participation requirements. Facilities that participate in Medicare may be surveyed on behalf of CMS by state survey agencies in order to determine whether the facilities are complying with federal participation requirements. 42 C.F.R. �� 488.10-488.28. The regulations contain special survey conditions for long-term care facilities. 42 C.F.R. �� 488.300-488.335.

Pursuant to 42 C.F.R. Part 488, a state or CMS may impose a per instance or per day CMP against a long-term care facility when a state survey agency concludes that the facility is not complying substantially with federal participation requirements. 42 C.F.R. �� 488.406; 488.408; 488.430. The regulations specify that a CMP that is imposed against a facility on a per day basis will fall into one of two broad ranges of penalties. The upper range of CMP, of from $3,050 per day to $10,000 per day, is reserved for deficiencies that constitute immediate jeopardy to a facility's residents, and in some circumstances, for repeated deficiencies. The lower range of CMP, from $50 per day to $3,000 per day, is reserved for deficiencies that do not constitute immediate jeopardy, but either cause actual harm to residents, or cause no actual harm but have the potential for causing more than minimal harm. There is only a single range of $1,000 to $10,000 for a per instance CMP. 42 C.F.R. �� 488.408; 488.438.

Pursuant to 42 C.F.R. � 488.301, "(s)ubstantial compliance means a level of compliance with the requirements of participation such that any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm." (emphasis in original).

The Act and regulations make a hearing before an administrative law judge (ALJ) available to a long-term care facility against whom CMS has proposed a CMP. Act, section 1128A(c)(2); 42 C.F.R. �� 488.408(g); 498.3(b)(12), (13). The hearing before an ALJ is a de novo proceeding. Anesthesiologists Affiliated, et al, DAB CR65 (1990), aff'd, 941 F2d. 678 (8^th Cir. 1991). A facility has a right to appeal a "certification of noncompliance leading to an enforcement remedy." 42 C.F.R. � 488.408(g)(1); see also 42 C.F.R. �� 488.330(e) and 498.3. However, the choice of remedies by CMS or the factors CMS considered when choosing remedies are not subject to review. 42 C.F.R. � 488.408(g)(2). A facility may only challenge the scope and severity level of noncompliance found by CMS if a successful challenge would affect the amount of the CMP that could be collected by CMS or impact upon the facility's nurse aide training program. 42 C.F.R. �� 498.3(b)(14) and (d)(10)(i). CMS's determination as to the level of noncompliance "must be upheld unless it is clearly erroneous." 42 C.F.R. � 498.60(c)(2). This includes CMS's finding of immediate jeopardy. Woodstock Care Center, DAB No. 1726, at 9, 38 (2000), aff'd Woodstock Care Center v. U.S. Dept. of Health and Human Services, 363 F.3d 583 (6^th Cir. 2003). The Departmental Appeals Board (the Board) has long held that the net effect of these regulations is that a provider has no right to challenge the scope and severity level assigned to a noncompliance finding, except in the situation where that finding was the basis for an immediate jeopardy determination. See, e.g., Ridge Terrace, DAB No. 1834 (2002); Koester Pavilion, DAB No. 1750 (2000).

When a penalty is imposed and appealed, CMS must make a prima facie case that the facility has failed to comply substantially with federal participation requirements. "Prima facie" means that the evidence is "(s)ufficient to establish a fact or raise a presumption unless disproved or rebutted." Black's Law Dictionary 1228 (8^th ed. 2004). To prevail, a long-term care facility must overcome CMS's showing by a preponderance of the evidence. Batavia Nursing and Convalescent Center, DAB No. 1904 (2004); Batavia Nursing and Convalescent Inn, DAB No. 1911 (2004); Emerald Oaks, DAB No. 1800 (2001); Cross Creek Health Care Center, DAB No. 1665 (1998); Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd Hillman Rehabilitation Center v. U.S. Dept. of Health and Human Services, No. 98-3789 (D.N.J. May 13, 1999).

C. DISCUSSION

This case arises from a standard survey conducted at Petitioner's facility on January 25, 2002, by the state agency. The results of the survey were recorded in the SOD dated January 25, 2002. CMS Exs. 1, 19; P. Ex. 1. The SOD was revised after IDR resulting in the deletion of three deficiencies (Tags F 166, F 242, and F 314). CMS Exs. 2, 3; P. Ex. 1. The remaining nine deficiencies included violations of 42 C.F.R. �� 483.20(b)(2)(ii) (Tag F 274); 483.20(k)(2) (Tag F 280); 483.20(k)(3)(i) (Tag F 281); 483.25 (Tag F 309); 483.25(a) (Tag F 311); 483.25(a)(3) (Tag F 312); 483.25(d)(2) (Tag F 316); 483.25(h)(2) (Tag F 324); and 483.75(f) (Tag F 498). The violation of section 483.25(h)(2) (Tag F 324) was alleged to have caused actual harm. Based on a revisit survey, it was determined that Petitioner was in substantial compliance with regulatory requirements as of March 16, 2002 and all remedies ceased effective March 15, 2002. CMS Ex. 4. Petitioner disputes the remaining nine deficiencies and the remedies proposed by CMS.

Prior to discussing the individual deficiencies, it is necessary to address the issue of the credibility of the surveyors. Petitioner attacks the credibility of the surveyors based on their lack of recent nursing experience and claims that the surveyors are not qualified as expert witnesses. This is an administrative proceeding to which the formal rules of evidence do not strictly apply. However, if I apply Fed. R. Evid. 702 and the decision in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), I find that the three surveyors (Truett, McClure and Kardasz) have scientific, technical or other special knowledge as nurse surveyors that can help me make a decision on the facts in issue. Thus, it was appropriate to allow them to testify to their opinions based upon the evidence, giving such weight as is appropriate in light of the factors listed in Fed. R. Evid. 702 - sufficiency of facts or data, reliability of principles or methods, and reliability of the application of principles or methods to the facts. Further, 42 C.F.R. � 488.26(c)(3) establishes a presumption of professional competence for surveyors. Petitioner bears the burden to rebut this presumption. In this case, the fact that the surveyors have been out of actual nursing practice for a period of years does not detract from their credibility or from the probative value of their testimony absent some evidence from a more credible source indicating that their knowledge of standards of practice is in error rather than just disputed. Petitioner also misses the primary point of the surveyors' testimony, which is to allow them to elaborate upon the reasons why they alleged deficiencies and to give Petitioner an opportunity to cross-examine them.

The qualifications of Petitioner's witnesses are reflected in the transcript and I have considered their testimony in light of their qualifications and whether or not they had first hand knowledge of the facts concerning the alleged deficiencies or whether they were offering opinions based only upon their record reviews and staff interviews. Petitioner had five witnesses testify: Ms. Alison Matthews, the Petitioner's nursing home administrator; Ms. Cindy Haitz, the Regional Director responsible for MDS auditing for Petitioner's parent corporation; Ms. Clare Forbin, a nursing consultant for Strategic Nursing Systems, an organization that consults with Petitioner and other facilities on clinical care issues; Ms. Carol Campbell, Petitioner's Director of Nursing (DON); and Ms. Kimberly Parks, Regional Director of Strategic Nursing Systems.

1. CMS has failed to make a prima facie showing that Petitioner was in violation of 42 C.F.R. � 483.20(b)(2)(ii) (Tag F 274).

Section 483.20 of 42 C.F.R. requires that a facility do a comprehensive assessment of its residents, initially upon their admission and periodically thereafter. The regulation requires a "comprehensive assessment" using a resident assessment instrument (RAI) with results being recorded and reported using the MDS. ⁽²⁾ The comprehensive assessment is to be done within 14 days of admission or readmission, and not less than once every 12 months thereafter, or when a significant change occurs. The resident assessment standard related to "significant change" is established by 42 C.F.R. � 483.20(b)(2)(ii), and requires that a comprehensive assessment be done:

(ii) Within 14 calendar days after the facility determines, or should have determined, that there has been a significant change in the resident's physical or mental condition. (For purposes of this section, a "significant change" means a major decline or improvement in the resident's status that will not normally resolve itself without further intervention by the staff or by implementing standard disease-related clinical interventions, that has an impact on more than one area of the resident's health status, and requires interdisciplinary review or revision of the care plan or both).

A quarterly review assessment is to be done with an instrument specified by the state and approved by CMS not less than every three months. 42 C.F.R. � 483.20(c).

The SOM ⁽³⁾ explains that the intent of 42 C.F.R. � 483.20 is to "provide the facility with ongoing assessment information necessary to develop a care plan to provide the appropriate care and services for each resident, and to modify the care plan and care/services based on the resident's status." SOM, App. P. at PP-68, Tag F 272, Guidance to Surveyors (May 1999). The SOM explains that the intent of 42 C.F.R. � 483.20(b) is to require facilities to use the state adopted and approved RAI for comprehensive assessments. The facility is to use resident observations, review of the resident's records, and communication with the resident, staff, the resident's physician, family members, and outside consultants to complete the RAI. The SOM further explains that the MDS and the RAI include the information required by 42 C.F.R. � 483.20(b)(1)(i-xvi), and those instruments and "triggered RAPs" (resident assessment protocols) are used to conduct comprehensive assessments. The SOM instructs surveyors, consistent with the regulation, that a comprehensive assessment is required for newly admitted residents, annual resident reassessments, and if there is a significant change in status. SOM, App. P. at PP-69, Tag F 272, Guidance to Surveyors. SOM, Tag F 273 (SOM, App. P. at PP-73) relates to the requirement of 42 C.F.R. � 483.20(b)(2)(i) that admission assessments be done within 14 days. SOM, Tag F 275 (SOM, App. P. at PP-74) relates to the requirement of 42 C.F.R. � 483.20(b)(2)(iii), that each resident be comprehensively reassessed not less than 12 months (366 days per the SOM) after final completion of the most recent comprehensive assessment using the RAI.

SOM, Tag F 276 (SOM, App. P. at PP-75) relates to the requirement of 42 C.F.R. � 483.20(c) which requires that each resident receive a quarterly review assessment. The Guidance to Surveyors section of Tag F 276 explains that the intent is that each resident's assessment is to be updated at least quarterly with review of those MDS items specified under the State's quarterly review form. The running of the period for conducting a quarterly review is triggered by the most recent assessment, initial, annual, or significant change.

Thus, the regulatory scheme as expanded upon in the SOM, is that within 14 days of admission a resident receives a comprehensive assessment using the RAI and MDS instruments. The resident's assessment is to be reviewed and updated quarterly. Not more than 12 months from the initial comprehensive assessment, the resident is to receive a comprehensive reassessment. However, if there is a significant change in the resident's mental or physical health, a significant change assessment is to be done, again using the RAI and MDS instruments. If there is a significant change assessment, then the dates of the quarterly review and annual reassessment are determined based upon the date of the significant change assessment. The results of these required assessments are used to establish and modify the resident's care plan. Comprehensive care planning is governed by 42 C.F.R. � 483.20(k) with survey requirements and guidance in the SOM under Tag F 279, appendix P at page PP-82.

The surveyors allege in the SOD that the facility failed in the case of Residents 14, 41, 45, and 79 to do a comprehensive assessment when the residents experienced a significant change, in violation of 42 C.F.R. � 483.20(b)(2)(ii). In order to show a prima facie violation of 42 C.F.R. � 483.20(b)(2)(ii), CMS must show that there was a significant change in the mental or physical health of one or more of these residents and that Petitioner failed to do, or inadequately did, a comprehensive assessment after Petitioner determined, or should have determined, that a significant change had occurred. It is not sufficient for CMS to simply allege Petitioner was in violation. The Board's definition of the requirements for a prima facie case from Hillman is helpful:

HCFA [now known as CMS] must identify the legal criteria to which it seeks to hold a provider. Moreover, to the extent that a provider challenges HCFA's findings, HCFA must come forward with evidence of the basis for its determination, including the factual findings on which HCFA is relying and, if HCFA has determined that a condition of participation was not met, HCFA's evaluation that the deficiencies found meet the regulatory standard for a condition-level deficiency.

DAB No. 1611, at 8. Thus, CMS has the initial burden of showing that its decision to impose a sanction is legally sufficient under the statute and regulations. To make a prima facie case that its decision was legally sufficient in this case, CMS must: (1) identify the statute, regulation or other legal criteria to which it seeks to hold Petitioner; (2) come forward with evidence upon which it relies for its factual conclusions that are disputed by the Petitioner; and (3) show how the deficiencies it found amount to noncompliance that warrants an enforcement remedy. CMS has not made a prima facie showing regarding this alleged deficiency.

a. Resident 14

Resident 14 had a Quarterly MDS done on September 6, 2001 (CMS Ex. 11 at 5) and on November 1, 2001 (CMS Ex. 11 at 130). The MDS is the instrument used to record and transmit RAI data to the state agency and CMS. Thus, a completed MDS is good evidence that the facility conducted a comprehensive assessment of the resident prior to the dates indicted on the MDS. The surveyors alleged in the SOD that the MDS dated November 2001 shows that Resident 14 had declines within the last 30 days prior to completion of the MDS. The surveyors correctly state that the MDS was coded as a quarterly and not a significant change MDS. The surveyors allege however, that no comprehensive assessment was done in connection with the MDS. CMS suggests that Resident 14 was not comprehensively assessed or that some additional assessment should have been done. CMS Brief at 12-13. There are two significant problems with the CMS position. First, the fact that an MDS was completed indicates that an assessment was done. If no assessment was done as alleged by CMS, where did Petitioner obtain the data to complete the MDS? CMS has not presented evidence from which I might conclude that the assessment evidenced by the MDS forms was incomplete or inadequate. CMS does not allege that the November 2001 MDS does not accurately reflect changes in Resident 14 since the last quarterly assessment. Second, CMS has not presented evidence that shows a significant change requiring any additional assessment occurred between September 6, 2001 (the date of the first MDS) and November 1, 2001 (the date of the second MDS) or between November 1, 2001 and January 25, 2002 (the date of the survey). After the November 1, 2001 MDS was completed, Resident 14 fell and sustained a fractured clavicle and the surveyors also alleged she experienced weight loss and general declines in unspecified abilities. CMS Ex. 19 at 6. My review shows that both the September and November 2001 MDS reflect that Resident 14 had a history of falls (CMS Ex. 11 at 9, 133) and the November 2001 MDS reflects weight loss (CMS Ex. 11 at 133). The injuries sustained from Resident 14's fall do not meet the definition of a significant change requiring an additional assessment. See 42 C.F.R. � 483.20(b)(2)(ii) (significant change is a major decline or improvement in a resident's status that will not normally resolve without additional interventions, that has impact on more than one area of resident's health status, and requires review or revision, or both, of the care plan).

The fact that the MDS instruments are coded quarterly rather than as a significant change, indicates that the MDS forms were done as quarterly assessment reviews. The regulation and SOM suggest that a quarterly review might be less comprehensive than the comprehensive assessments required initially, annually, and for significant changes. However, nothing prohibits or prevents a facility from doing a comprehensive assessment as part of a quarterly review. The use of the MDS, which is designed for recording and transmitting information gathered by the RAI used for a comprehensive assessment pursuant to 42 C.F.R. � 483.20(b)(1), for the quarterly review raises at least a rebuttable presumption that that review was, in fact, a comprehensive assessment such as that required for initial, annual and significant change assessments. CMS never presents evidence as to what was actually involved in the assessments and whether or not they included all the elements specified by 42 C.F.R. � 483.20(b)(1). Furthermore, I find nothing in the regulations or the SOM that requires that a comprehensive assessment must be coded on the MDS as a quarterly or a significant change or an annual, when one or more of these characterizations may be appropriate.

The regulation does not require that both a significant change assessment and quarterly assessment be done when the quarterly is comprehensive and already covers any changes in the resident. The regulation does not require that an assessment be duplicated. Additionally, the regulation only requires that an assessment be done when a significant change occurs that meets the definition specified in 42 C.F.R. � 483.20(b)(2)(ii). In this case, the quarterly MDS already captured that Resident 14 had a history of falls and weight change. CMS has not shown that after the November 2001 MDS there was a significant change, either decline or improvement, that required another assessment or that existing interventions under the care plan in effect were inadequate or ineffective in light of the quarterly assessments.

b. Resident 41

According to a MDS with an assessment reference date of August 16, 2001, Resident 41 suffered from congestive heart failure, chronic obstructive pulmonary disease (COPD), anemia, hearing loss, renal insufficiency, renal obstruction, and paranoia. P. Ex. 12 at 69. According to her MDS with an assessment reference date of November 7, 2001, Resident 41 had the same diagnosis but she had also suffered a urinary tract infection and a respiratory infection within the last 30 days. P. Ex. 12 at 51. The surveyors allege in the SOD that comparison of the quarterly MDS in August 2001 and November 2001 reflected "decline in multiple areas of activities of daily living, cognition, bowel and bladder, communication, and weight loss." CMS Ex. 19 at 6. The surveyors allege that the change in function in the various areas was not acknowledged when indicated on the MDS of November 7, 2001. The surveyor's complaint is that no significant change assessment was completed for Resident 41.

I reject this alleged violation for the same reasons already discussed in connection with Resident 14. The MDS completed by the facility is the source of the surveyor's information and the data for the MDS must have come from some sort of assessment, but CMS again fails to show that that assessment was deficient. Comparing the MDS of August 2001 with the MDS of November 2001, it is clear that Resident 41 experienced decline in several areas. However, the November 2001 MDS clearly indicates that Resident 41 had recently experienced both a urinary tract infection and a respiratory infection, generally short-term illnesses, and CMS does not point to evidence showing that Resident 41's declines were attributable to some significant change rather than those infections.

I conclude as I did with Resident 14, that CMS has not shown that there was a significant change not covered by the MDS of August 16, 2001 and November 7, 2001 or that a comprehensive assessment was not done to complete those MDS's.

c. Resident 45

The surveyors allege in the SOD that Resident 45 received an initial comprehensive assessment on September 6, 2001 and a quarterly assessment on November 28, 2001. CMS Ex. 19 at 6-7; CMS Ex. 20 at 2. The surveyors cited a deficiency because there was apparent decline between the two assessments but Petitioner did not do a significant change assessment. CMS Ex. 19 at 7, Tr. 136. Resident 45's diagnoses included diabetes mellitus, hypertension, Alzheimer's, Parkinson's, end-stage cerebral vascular disease, and gastroesphogeal reflux disease (GERD) according to the MDS with the assessment reference date of November 28, 2001. P. Ex. 10 at 5. The MDS also shows that Resident 45 was in hospice care. P. Ex. 10 at 7.

My conclusion is the same as for Residents 14 and 41. CMS has not shown that the assessment done for the November 2001 MDS was inadequate or not comprehensive or that another assessment was required before the survey. The surveyor who cited this deficiency, Jackie Kardasz, agreed on cross-examination that a significant change assessment is optional for a resident in end-stage. Tr. 144-45.

d. Resident 79

The surveyors cite the example of Resident 79 because he "was scheduled for a significant change assessment . . . on 01/14/02. As of . . . 01/25/02 the assessment was not completed and available for review on the medical record." CMS Ex. 19 at 7. The regulation at 42 C.F.R. � 483.20(b)(2)(ii) provides that the facility has 14 days in which to complete a comprehensive assessment following a significant change. Given the facts alleged by the surveyor, the facility had until January 28, 2002 to complete the assessment. Since the survey was conducted on January 25, 2002, the facility still had three days in which to complete the assessment. The surveyor did not allege that the assessment was not in progress. Neither the testimony nor CMS briefing helps clarify the surveyor's allegations.

CMS has failed to make a prima facie showing of a violation of 42 C.F.R. � 483.20(b)(2)(ii) (Tag F 274) by any of the examples cited by the surveyors.

2. Petitioner violated 42 C.F.R.� 483.20(k)(2)(Tag F 280).

The resident assessment standard is established by 42 C.F.R. � 483.20(k)(2), which provides:

A comprehensive care plan must be

(i) Developed within 7 days after the completion of the comprehensive assessment;

(ii) Prepared by an interdisciplinary team, that includes the attending physician, a registered nurse with responsibility for the resident, and other appropriate staff in disciplines as determined by the resident's needs, and, to the extent practicable, the participation of the resident, the resident's family or the resident's legal representative; and

(iii) periodically reviewed and revised by a team of qualified persons after each assessment.

The surveyors allege that the regulatory requirement was not satisfied for Residents 30 and 27.

a. Resident 30

The surveyors allege that Resident 30 was diagnosed with an antibiotic resistant respiratory infection on November 30, 2001, and required respiratory isolation, which was still in effect on the date of the survey, January 25, 2002. The surveyors further allege that they reviewed Resident 30's care plans and they had not been updated to show that Resident 30 required respiratory isolation. The surveyors also allege that the care plans did not indicate the precautions the staff needed to take when having contact with Resident 30. CMS Ex. 19 at 8. Laura McClure, the surveyor who cited the deficiency testified that she was concerned because Resident 30's care plan had not been reviewed and revised to deal with his current needs given the fact that he was in respiratory isolation. Tr. 125-126.

Resident 30 had a long-term care plan dated November 2, 2001, related to her activity status. The plan reflects that Resident 30's activity status is affected by her diagnosis of depression and arthritis and she did not attend group activity. The plan provides for minimal one-on-one activities. The plan does not reflect any changes about the time she began respiratory isolation through the date of the survey. P. Ex. 11 at 15. No reference to her activity status, depression, or arthritis is made on her acute plan of care requiring respiratory isolation. P. Ex. 11 at 16.

Petitioner does not deny that Resident 30's activity care plan was not updated. Petitioner's witness Cindy Haitz testified that Resident 30's respiratory isolation had no impact on her activity level as most of her activities were limited to her room. Tr. 204. Petitioner argued that no change in Resident 30's activities care plan was required as she was care planned for one-on-one activities and she still had her puppets and television. P. Brief at 6.

Isolation necessarily limits staff contact and contact with other residents. The limitation on contact due to the isolation was a change from the conditions and circumstances that existed when Resident 30's activities care plan was developed. Therefore, CMS made a prima facie showing that Petitioner failed to periodically update and review Resident 30's care plan. Petitioner's post hoc rationalization that no change in the care plan was necessary does not satisfy the regulatory requirement to review and update that care plan.

Accordingly, I conclude that this example reflects a violation of 42 C.F.R. � 483.20(k)(2), specifically subsection (iii). ⁽⁴⁾ Further, given Petitioner's diagnosis of depression and arthritis, it is apparent to me that more than minimal harm is possible.

b. Resident 27

The surveyors allege two problems through the example of Resident 27. They allege that Resident 27 had "ongoing development of multiple pressure sores without evidence of evaluation of the pressure reduction devices, and changes of interventions. . . . " CMS Ex. 19 at 9. The surveyors also allege that Resident 27 had been documented by nursing staff to resist care, but Petitioner failed to develop interventions to address the problem. Id.

The surveyor's assertions concerning pressure reduction devices are incorrect as indicated by the Petitioner's form entitled Plan of Care Preventive Skin Care. CMS Ex. 13 at 46, 88. The Plan of Care Preventive Skin Care was initiated on July 31, 2001 and renewed on October 31, 2001, January 31, 2002 and April 30, 2002. A pressure reduction mattress and heel guards were, in fact, assessed and implemented. Id.

Nursing notes for Resident 27 covering the period July 18, 2001 through January 22, 2002, were offered and admitted as CMS Ex. 13 at 5-36. My review of the notes reflects that in July and most of August 2001, Resident 27 was noted to have few behavior problems, although a note from August 29, 2001, indicates she would yell "help" when she wanted ice cream and when she finished her ice cream. Id. at 11. However, Resident 27 was noted to be cooperative with care in early September 2001. Id. at 12. Resident 27 continued to yell "help" occasionally during September. Id. at 13, 15, 16. A note from October 4, 2001, indicates that Resident 27 continued to be cooperative with care (Id. at 17), although a note from September 15, 2001 records that she refused to go to the hospital (Id. at 14). A note from October 10, 2001, indicates that Resident 27 continued with occasional yelling out. Id. at 19. A note from October 15, 2001, records that Resident 27 refused to cooperate with care by lying down after meals and elevating her legs as directed. Id. A November 1, 2001 note indicates the resident spit-out her medication. Id. at 21. A weekly charting note from November 8, 2001, indicates that Resident 27 yells continually while up in her wheelchair, she hits staff when they attempt to give personal care, and sometimes yells out at night. Id. Resistance to care is also noted on November 22, 2001 (Id. at 27), November 23, 2001 (Id. at 26), December 5, 2001 (Id. at 30), December 13, 2001 (Id. at 32), December 18, 2001 (Id. at 33), December 25, 2001 (Id. at 34), and January 8 and 15, 2001 (Id. at 35).

Petitioner had a care plan for Resident 27's socially inappropriate behaviors with other residents. Id. at 57, 42, 44. However, I have received no evidence that Petitioner specifically care planned for Resident 27's resistence to care, even though it manifested as early as October 15, 2001 and with some regularity thereafter. A social service progress note dated January 16, 2002, reflects Resident 27's resistence to care. Id. at 91. I have in evidence Chronic Mood/Behavior Weekly Summaries for Resident 27 from November 21, 2001, January 9, 2002, January 16, 2002, and January 23, 2002, which show that Petitioner's staff was aware of the problem and were attempting interventions. Id. at 69, 72, 73, 75. However, I have been presented with no care plan prior to the survey. On January 24, 2002, during the survey, Petitioner's staff provided the surveyors another copy of Resident 27's care plan for socially inappropriate behavior ( Id. at 57) with an additional problem, goal, and interventions related to the resident's resistance to care. The changes to the care plan were undated when presented to the surveyors but staff dated the changes January 24, 2002 when requested. Id. at 90.

Petitioner's witness, Cindy Haitz, testified that she did not think Resident 27 should be cited as an example as Petitioner did an MDS on January 17, 2002 and the care plan was updated on January 24, 2002, within the seven-day period allowed. Tr. 204. However, Ms. Haitz's testimony does not address the failure of Petitioner to review and revise Resident 27's care plan to address her resistance to care during the period October through December 2001.

Based upon the foregoing facts, I conclude that Petitioner was not in substantial compliance with 42 C.F.R. � 483.20(k)(2)(iii) (F 280) with regard to Resident 27 as Petitioner failed to review and revise her comprehensive care plan to deal with her resistence to care. Petitioner's failure to care plan for Resident 27's resistence to medically appropriate care presented the risk for more than minimal harm to her.

I conclude that Petitioner was in violation of 42 C.F.R. � 483.20(k)(2) and that there was a potential for more than minimal harm to both Resident 30 and Resident 27.

3. Petitioner violated 42 C.F.R. �� 483.20(k)(3)(i)(Tag F 281).

The resident assessment standard is established by 42 C.F.R. � 483.20(k)(3)(i), which provides:

The services provided or arranged by the facility must -

(i) Meet professional standards of quality.

The surveyors allege that Petitioner did not satisfy this regulatory requirement as to Resident 68 because Resident 68's intake and output were not recorded every shift as required by her care plan and daily temperatures were not taken as required by the physician's orders. CMS Ex. 19 at 10. A review of Petitioner's own records clearly establishes CMS's prima facie case, which is unrebutted.

There is no dispute that Resident 68 was dependent on Petitioner for all activities of daily living and diagnosed with deteriorating multiple sclerosis, diabetes, and chronic urinary tract infections. This resident was fed and received flushes of water six times a day for hydration through a gastrostomy tube. Id. Resident 68 had a doctor's order that required Petitioner to take the resident's temperature daily and to report to the doctor if the temperature exceeded 101. CMS Ex. 4 at 80, 82. Resident 68's care plan required that Petitioner monitor and record Resident 68's consumption. Id. at 37.

The November 2001 medication administration record (MAR) reflects that Resident 68's temperature was not recorded twice during the month. CMS Ex. 17 at 49. The December 2001 MAR shows that the facility failed to take Resident 68's temperature all month but once. Id. at 47. The January 2002 MAR shows no recording of temperature for 22 out of 24 days. Id. at 46. Several other MAR sheets were provided to me on which Resident 68's intake and output were to be recorded. However, these sheets were copies and I can only assume that the month and year on these forms were cut off during the copying process. All the intake and output sheets provided to me show gaps. Id. at 48, 50, 51; P. Ex. 4 at 93, 97, 99. In particular, the only sheet referred to by Petitioner in its brief (P. Ex. 4 at 93) shows 20 gaps during the 7 p.m. to 7 a.m. shift. It is evident that Petitioner failed to consistently record consumption and daily temperatures. This failure placed Resident 68 at risk for dehydration, nutritional lapse, and infection. I conclude that Petitioner was not in substantial compliance with 42 C.F.R. � 483.20(k)(3)(i)(F 281) and that there was a potential for more than minimal harm to Resident 68.

4. Petitioner violated 42 C.F.R. � 483.25 (Tag F 309).

The general quality of care standard is established by 42 C.F.R. � 483.25:

Each resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psycho social well-being, in accordance with the comprehensive assessment and plan of care.

The surveyors allege that Petitioner did not satisfy this regulatory requirement as to Resident 14, Resident 2, Resident 35, and Resident 68.

a. Resident 14

Petitioner assessed Resident 14 as at risk for skin breakdown due to her congestive heart failure with resulting edema, hypertension, arthritis, history of cardiovascular accident with decreased sensitivity to pain and pressure, dementia, poor nutrition and hydration, Parkinson's disease, anemia, and incontinence. CMS Ex. 11 at 62. The earliest nursing notes provided to me show that Resident 14 had a history of skin tears. Id. at 12. On December 5, 2001, Resident 14 was found with a nine by four-centimeter, "L" shaped skin tear on her left forearm that she could not explain. The nurse notes show that a new intervention was implemented which required Resident 14 to wear "geri-sleeves" on both arms. Id. at 23. Resident 14's plan of care for preventive skin care initiated October 28, 2001, shows that geri-stockings were added as an intervention on January 23, 2002. Id. at 30. The surveyor recorded in the SOD that staff told her that Resident 14 had a history of scratching herself. CMS Ex. 19 at 11; Tr. 48-49.

According to the SOD, the surveyor observed Resident 14 on January 22, 2002 at 10:02 a.m. and from 12:57 p.m. to 1:24 p.m. and the resident was not wearing any protective devices on her arms or legs. CMS Ex. 19 at 11. The surveyor observed Resident 14 again around 7:07 a.m. on January 23, 2002 and she had "stocking sleeves on both lower legs." Id. at 11-12. At about 4:00 p.m., on January 23, the surveyor asked to see the resident's lower legs and saw a skin tear and purple bruise on the back of the resident's right lower leg and there was a bandage on the back of the left calf near the ankle covering a skin tear. The surveyor alleged that facility documents show skin tears on the right and left lower legs probably due to scratching as the resident appeared to have blood under her fingernails. Id. The surveyor also observed that Resident 14 had long, jagged, dirty fingernails. Id. at 12. On January 24, 2002 at 8:30 a.m. and again on January 25, 2002 at 10:20 a.m., the resident was observed without the protective stockings on. Id.

Petitioner does not dispute that Resident 14 had problems scratching herself causing skin tears or that the resident was to wear geri-stockings and geri-sleeves. Petitioner offered testimony that the problem with Resident 14 was she was noncompliant and removed both the stockings and sleeves. Tr. 221, 237. Petitioner argued that Resident 14 was "at the end stage of her life and she expired shortly after the survey" and there was no need to agitate her by requiring her to wear the geri-stockings and geri-sleeves. P. Brief at 9.

I do not accept Resident 14's alleged noncompliance with wearing the geri-stockings and sleeves as an adequate defense in this case. Petitioner has not shown that reasonable steps, including alternative interventions, were undertaken to overcome Resident 14's noncompliance and resistance to care, and that, in spite of those reasonable steps Resident 14's noncompliance and resistence continued to interfere with treatment attempts. Rather, Petitioner argues that, "[s]taff's feeling was that there was no purpose in agitating a resident who would soon be dead by requiring them to wear clothing or stockings which they did not like and which caused them to be agitated." P. Brief at 9. Petitioner's argument admits that staff gave-up with regard to Resident 14 and attempts to prevent her from harming herself by scratching and causing skin tears.

Resident 14 was also kyphotic ⁽⁵⁾ and as a result she leaned forward most of the time when seated. CMS Ex. 11 at 41, 60, 65, 79, 82, 117. The surveyor observed Resident 14 in the dining room for approximately one-half hour on January 22, 2002. Resident 14 repeatedly leaned her face and chin into and on the food plate. CMS Ex. 19 at 12-13. On January 23, 2002, the surveyor observed Resident 14 restrained in her wheelchair between 9:12 a.m. and 10:36 a.m. but completely leaned forward with her head on her knees. Id. at 13. The surveyor alleged that multiple staff passed the resident and no staff member came to assist Resident 14 in her positioning. Id.; Tr. 49-52; 191-192.

Petitioner does not dispute the surveyor's observations but notes that there was an occupational therapy evaluation regarding correct positioning of Resident 14 in her wheelchair. P. Brief at 9. Surveyor Truett indicated in testimony that her concern in citing the deficiency is that staff did not reposition Resident 14 for comfort or safety. Tr. 52. Petitioner's occupational therapy evaluation and plan of care for Resident 14 indicates that staff will monitor and address positioning needs and safety as necessary. CMS Ex. 11 at 79. An occupational therapy progress note/plan of care with dates in October 2001 indicates the goal that Resident 14 sit upright in her wheelchair 100 percent of the time with a foam cushion to accommodate her kyphosis, without falls. Id. at 82-83. The surveyor's observations reveal that the care plan was not being followed or the goal met. Petitioner's noncompliance with the plan also put Resident 14 at increased risk for falls as acknowledged by Petitioner's Administrator, Allison Matthews. Tr. 191.

I conclude that Petitioner was not in substantial compliance with 42 C.F.R. � 483.25 (F 309) and that there was a potential for more than minimal harm to Resident 14.

b. Resident 2

Resident 2 was incontinent of bowel and bladder, had a history of stage IV pressure sores, and assessed as totally dependent upon two or more staff for bed mobility, locomotion, and toileting. CMS Exs. 10, 11 at 13. There were care planned interventions for Resident 2 including: repositioning every two hours, application of heel protectors when in bed, checking for incontinence every two hours, and providing perineal care after incontinent episodes. P. Ex. 3 at 1-3, 35, 37-38, 49; CMS Ex. 10 at 8.

On January 22, 2002, the surveyor observed Resident 2 in bed at 10:20 a.m. and again at 1:45 p.m. with heels directly on the mattress without heel protectors on and the heel protectors were not found in the bed. On January 23, 2002, between 7:00 a.m. and 11:06 a.m. the surveyor observed the resident in bed without heel protectors. Staff also failed to reposition the resident, to provide any incontinence care, or remove a soaked incontinent pad. CMS Ex. 19 at 13-14; Tr. 57-58. At three other times during the survey, Resident 2 was observed with heels directly on the mattress without heel protectors on. CMS Ex. 19, at 14-15.

Petitioner argues that Resident 2 was noncompliant with turning, was on a pressure relief mattress which helps prevent pressure sores, and heel bows were used. P. Brief at 10-11. Petitioner's witness, Ms. Forbin, actually testified that heel bows had been attempted but she gave no detail as to when or why they were discontinued, or how they differed from heel protectors. Tr. 222. Ms. Forbin did confirm the surveyor's observation that on January 24, Resident 2 was in bed without heel protectors and she explained that was because they had been sent to be cleaned or to order a new pair. Tr. 223. Ms. Forbin did not explain why Resident 2 was observed on other occasions without heel protectors. Petitioner does not explain why Resident 2's noncompliance with turning prevented staff from attempting to turn her during periods of observation by the surveyor. Petitioner suggests that Surveyor Truett's testimony that Resident 2's incontinent pad was wet (Tr. 58) and her report that the pad was urine saturated (CMS Ex. 19 at 14) at 10:30 a.m. on January 24, 2002, are not credible. P. Brief at 10. However, Petitioner does not cite any evidence that causes me to doubt the accuracy of Ms. Truett's direct observations. Certainly, the testimony of Petitioner's witness, Ms. Forbin, that cold air might have caused Resident 2 to suddenly void, is totally speculative and does not cause me to question the accuracy of Ms. Truett's observation that the pad was wet. Furthermore, Petitioner never explains why if a pressure relieving mattress is sufficient to prevent pressure sore development, Resident 2's care plan was not modified to delete the requirements for heel protectors and turning.

I conclude that Petitioner was not in substantial compliance with 42 C.F.R. � 483.25 (F 309) and that there was a potential for more than minimal harm to Resident 2.

c. Resident 35

Resident 35 had multiple significant diagnoses including quadriplegia due to a cervical injury, neurogenic bladder, a history of deep vein thrombosis, hypertension, a history of urosepsis, and chronic statis ulcers. P. Ex. 13 at 4. Dietary progress notes from January 17, 2002 and January 31, 2002, show that Resident 35 had a stage 3 ulcer on his left heel and a stage 2 ulcer on his right ankle before the survey, and that the ulcer on the right ankle worsened to a stage 3 after the survey. Id. at 8. The resident's physician had issued orders to keep both the resident's heels elevated off the bed at all times to relieve pressure. Id. at 77, 92. There is no evidence that the order to keep heels elevated was discontinued until January 29, 2002, after the survey. CMS Ex. 14 at 29. The surveyor records in the SOD that she observed Resident 35 with his heels on the bed and not elevated. CMS Ex. 19 at 15; Tr. 126-28, 129-30. The evidence CMS has presented shows that Petitioner failed to follow the physician's order and is a prima facie showing of a violation of quality of care requirements.

Petitioner does not deny the surveyor's observations and, in fact, Petitioner's Administrator was present when the resident's heel was in contact with the bed. Tr. 244. Petitioner's argument is that there were other interventions in place including a special mattress and the resident was using a special boot at least on one foot so elevation was not always necessary. Petitioner argues that Resident 35 was noncompliant and abusive to staff and demanded that his foot not be elevated, a demand with which Petitioner argues it had to comply because a resident has the right to refuse treatment. P. Br. at 12-13; Tr. 245-49.

Petitioner's evidence and argument does not disprove or rebut the CMS prima facie showing of a violation. There is no dispute that there were physician orders in effect that Petitioner did not comply with. If the resident's physician and treatment team considered other interventions sufficient without the order to elevate the heels, then the orders should have been modified accordingly to make clear to the resident, staff and the surveyors what treatment was required. The fact that the resident refused treatment or was noncompliant occasionally is reflected in the documentary evidence. See e.g. CMS Ex. 14 at 22. However, I do not find noncompliance or refusal of treatment a defense in this case. The resident's refusal and noncompliance are documented in treatment records and the treatment team and physician were presumptively aware of what was documented. Nevertheless, the resident's treatment team and physician did not discontinue the order to elevate. So long as that order was in effect, elevation remained one of the interventions the facility was to implement. Petitioner's failure to comply with the physician's orders put Resident 35 at risk for further skin breakdown and pressure sores.

I conclude that Petitioner was not in substantial compliance with 42 C.F.R. � 483.25 (F 309) and that there was a potential for more than minimal harm to Resident 35.

d. Resident 68 ⁽⁶⁾

CMS did not offer the testimony of Surveyor Bewanger, who made the allegations in the SOD related to Resident 68. Thus, the evidence considered regarding the alleged violation related to Resident 68 is the SOD (CMS Ex. 19 and P. Ex. 1), the surveyor's packet including her notes and documents provided to her by the facility (CMS Ex. 17) and Petitioner's records for Resident 68 at P. Exs. 2, 4, and 16.

It is alleged in the SOD that Resident 68 had a physician's order to wear bilateral foot splints from 11:00 a.m. to 5:00 p.m.; but, the surveyor observed the resident without the required splints on January 22, 2003 at 1:00 p.m. and 3:40 p.m. and on January 23, 2002 at 12:40 p.m. and 3:30 p.m. CMS Ex. 19 at 15-16. The physician's orders are at CMS Ex. 17 at 41; P. Ex. 2 at 29.

Petitioner does not deny that there was an order for bilateral foot splints effective at the time of the survey or that the surveyor did not observe the resident without the splints. Rather, Petitioner argues that Resident 68 grimaced or seemed to be in pain when using the bilateral foot splints and so they were removed. Petitioner argues that several evaluations had been done and a special wheelchair had been ordered. P. Br. at 11. The testimony of Petitioner's witness was consistent except that she did not indicate when the decision was made to order a wheelchair or that it was on order at the time of survey.

Tr. 227-28. I find no evidence that the physician authorized Petitioner to deviate from his order or that the treatment team recommended that the order be discontinued. I find no reason to excuse Petitioner's failure to comply with the physician's order.

The surveyor also alleged in the SOD that Resident 68's care plan required that facility staff visit the resident every day for social interaction. However, the surveyor alleges that Resident 68 received only seven one-on-one visits from September 3, 2001 through December 20, 2001, and five one-on-one visits during the 24 days of January until the time of the survey. CMS Ex. 19 at 16.

Resident 68's "Long Term Plan of Care" dated November 2, 2001, indicates that she was unable to initiate her own activity and group involvement was limited placing her at risk for social isolation. Planned interventions included daily staff visits in addition to staff talking to her during care to provide "verbal tactile stimulation." P. Ex. 2 at 64-65. Petitioner invites my attention to the charting of visits as documented at P. Ex. 2 at 12. The charts are for December 2001 and January 2002, and record one to three visits per week. Id. at 62-63. Ms. Forbin testified that the goal on Resident 68's care plan was for her to have one-on-one activities in her room with the activity department for 10 to 15 minutes. Tr. 228. Her testimony is consistent with my review of the care plan which indicates that that visit is to be charted as it appears to have been for at least two months on P. Ex. 2 at 62-63. Ms. Forbin explained that the activity visits were in addition to the care planned daily staff visits which were concurrent with the resident's daily care. Tr. 228. Based upon my review of the evidence, I conclude that CMS has failed to show that Petitioner was not performing Resident 68's activity care plan.

I conclude that Petitioner was not in substantial compliance with 42 C.F.R. � 483.25 (F 309) with respect to at least one alleged example for each of Residents 14, 2, 35, and 68 and that there was a potential for more than minimal harm to each resident.

5. Petitioner did not violate 42 C.F.R. � 483.25(a)(2) (Tag F 311) with respect to Resident 14.

The general quality of care standard is established by 42 C.F.R. � 483.25(a)(2), which provides:

A resident is given the appropriate treatment and services to maintain or improve his or her abilities specified in paragraph (a)(1) of this section (referring to activities of daily living.)

The surveyors allege that Petitioner did not satisfy this regulatory requirement as to Resident 14 because the "resident was not provided with services and care to allow participation to maintain or restore her/his abilities of activities of daily living." CMS Ex. 19 at 18. More specifically, the surveyor alleged that she observed the resident in the morning on January 23, 2002, and the resident was not given the opportunity or encouraged to participate in bathing, dressing, personal hygiene, brushing her hair, or mouth care. Id. at 17-18.

There is no dispute that the resident's care plan recognized that she had a self-care deficit and required limited to extensive assistance with her activities of daily living due to her limited range of motion to all extremities and dementia. The care plan required staff to set-up, supervise, assist, and complete activities of daily living and oral care every day and as necessary. The care plan also required that staff encourage Resident 14 to complete her activities of daily living as she was able. CMS Ex. 11 at 67. There is also no dispute that Resident 14's last MDS preceding the survey with an assessment reference date of November 1, 2001, shows she required extensive assistance with personal hygiene and dressing during three of the seven days of the assessment period. Id. at 131. Resident 14 also had a history of resisting care. Id. at 118. Surveyor Truett testified that she made the observations alleged. She testified that in her opinion Resident 14 had experienced a significant decline and that Resident 14 had sustained a fracture as a result of a fall. Ms. Truett admitted that she could not assess Resident 14's ability to participate in activities of daily living at the time she made the observations. Tr. 61-63.

Given the foregoing facts, I conclude that CMS has not established a violation of 42 C.F.R. � 483.25(a)(2). The care plan provided that the resident was to participate as able. My reading of the regulation is that it requires no more. There was no evidence that Resident 14 was able or willing to participate in the activities of daily living during the time she was observed by the surveyor.

6. Petitioner violated 42 C.F.R. � 483.25(a)(3) (Tag F 312).

The general quality of care standard is established by 42 C.F.R. � 483.25(a)(3), which provides:

A resident who is unable to carry out the activities of daily living receives the necessary services to maintain good nutrition, grooming, and personal and oral hygiene.

The surveyors allege that Petitioner did not satisfy this regulatory requirement as to Resident 2, Resident 26, and Resident 27.

a. Resident 2

Resident 2 was incontinent of bowel and bladder, had a history of stage IV pressure sores, and assessed as totally dependent upon two or more staff for bed mobility, locomotion, and toileting. CMS Ex. 10, 11 at 13. There were care planned interventions for Resident 2 including: repositioning every two hours, application of heel protectors when in bed, checking for incontinence every two hours, and providing perineal care after incontinent episodes. P. Ex. 3 at 1-3, 35, 37-38, 49; CMS Ex. 10 at 8.

On January 23, 2002, between 7:00 a.m. and 11:06 a.m. the surveyor observed the resident in bed. According to the surveyor, staff failed to reposition the resident, to provide any incontinence care, or remove a soaked incontinent pad during that period. CMS Ex. 19 at 13-14; Tr. 57-58.

Petitioner does not specifically deny the surveyor's observations but suggests they were not accurate or may be susceptible to other interpretation. P. Brief at 14. Petitioner implies that something might have happened that Ms. Truett did not observe because Ms. Truett did not constantly observe Resident 2 during the period in question. Petitioner's argued implication, which Petitioner never specifically alleges, does not constitute evidence that causes me to doubt the accuracy or credibility of Ms. Truett's testimony about her observations. Petitioner also suggests that Surveyor Truett's testimony that Resident 2's incontinent pad was wet (Tr. 58) and her report that the pad was urine saturated (CMS Ex. 19 at 14) at 10:30 a.m. on January 24, 2002, are not credible. P. Brief at 10. However, Petitioner does not cite any evidence that causes me to doubt the accuracy of Ms. Truett's direct observations. Certainly, the testimony of Petitioner's witness, Ms. Forbin, that cold air might have caused Resident 2 to suddenly void, is totally speculative and does not cause me to question the accuracy of Ms. Truett's observation that the pad was wet.

CMS has made a prima facie showing and Petitioner has shown no defense.

b. Resident 26

Resident 26, a resident who was totally dependent on the staff for all care including bathing and personal hygiene, was observed by the surveyor with hair that was dirty, greasy and hanging in clumps. Tr. 65; CMS Ex. 19 at 20. This is sufficient evidence that Resident 26 was not receiving services necessary to maintain good grooming and personal hygiene.

Petitioner argues that Resident 26's medicated shampoo had been discontinued by her physician, a fact agreed to by Surveyor Truett. Tr. 107. Ms. Forbin testified for Petitioner that Resident 26 had naturally oily hair and even after being showered her hair would still remain oily and greasy. Tr. 229. Petitioner presented no evidence as to when Resident 26 had last had her hair washed. Petitioner does not explain why Resident 26's hair appeared dirty in addition to having a greasy appearance, and does not offer any explanation for why her hair was not brushed or combed. Petitioner presents no credible defense.

c. Resident 27

On January 22, 2002, Resident 27 was observed by the surveyor at various times during a six-hour period, in various locations in the facility including the dining room and halls, wearing slacks that were split or torn on both sides, exposing the sides of her briefs and upper thighs. The surveyor observed that after incontinence care the same torn slacks were placed back on Resident 27. CMS Ex. 19 at 20-21.

Petitioner argues that Resident 27 usually covered her slacks with a blanket and Resident 27's family did her laundry and provided her with the torn slacks to wear. Tr. 230; P. Brief at 15. Petitioner offers no evidence that it attempted to intervene with Resident 27's family to ensure that appropriate clothing was provided for Resident 27. Whether or not Petitioner has a regulatory requirement to provide decent clothing is not the issue. Petitioner's problem is that it has not presented me any evidence to show that it made any effort to ensure that Resident 27 was appropriately groomed.

7. Petitioner violated 42 C.F.R. � 483.25(d)(2) (Tag F 316).

The general quality of care standard is established by 42 C.F.R. � 483.25(d)(2), which provides:

Based on the resident's comprehensive assessment, the facility must ensure that-

A resident who is incontinent of bladder receives appropriate treatment and services to prevent urinary tract infections and to restore as much normal bladder function as possible.

The surveyors allege that Petitioner did not satisfy this regulatory requirement as to Resident 14 and Resident 27.

a. Resident 14

Resident 14's MDS with an assessment reference date of September 6, 2001, rates her as usually continent, with bladder incontinence of once a week or less and bowel incontinence of less than weekly. CMS Ex. 11 at 8. She was rated as requiring limited assistance for toileting. Id. at 7. The MDS with a reference date of November 1, 2001, shows that Resident 14 was assessed as usually continent of bowel (less than one incontinence event per week) but frequently incontinent of bladder (incontinent daily). Id. at 132. She was also evaluated in November 2001 as requiring the extensive assistance of one person for toilet use. Id. at 131. The resident's care plan required that staff anticipate and promptly meet Resident 14's toileting needs. The care plan also required that staff check for incontinence every two hours and as necessary with pericare after any episode of incontinence. Id. at 68. Her care plan also required a one to two person assist for transfers. Id. at 67.

The surveyor alleged that on January 23, 2002 from about 7:07 a.m. to 12:10 p.m., she saw no staff offer to assist Resident 14 with toileting although she observed that incontinence care was provided. Tr. 66-69; CMS Ex. 19 at 29-30.

Petitioner does not deny these observations but instead argues that toileting occurred when the surveyor was not looking or Resident 14 used the toilet herself when not observed. P. Brief at 16; Tr. 265. Petitioner presents no evidence that toileting occurred but invites speculation that it did, either with or without staff assistance. Speculation will generally not overcome testimony of direct observation. I also note that the surveyor observed staff remove a soiled incontinent brief at 7:07 a.m. and incontinence care was provided again at 10:36 a.m. as the resident had been incontinent of bowel and bladder. If I was inclined to speculate, it would be that two instances of incontinence in a three and one-half hour period, is inconsistent with the resident having used the toilet during that same period, absent some evidence of illness that would provoke such frequency. No speculation is required about the fact that Petitioner had assessed Resident 14 as requiring a one to two person physical assist for transfers and toileting. Unless Petitioner's assessment was wrong or staff was simply ignoring the care plan, Resident 14 should not have been using the toilet alone. I do not find Petitioner's position credible.

I conclude that Petitioner violated 42 C.F.R. � 483.25(d)(2) with respect to Resident 14 and that there was a potential for more than minimal harm as a result.

b. Resident 27

Resident 27 was assessed as being frequently incontinent of bladder (CMS Ex. 13 at 49) and as requiring extensive assistance to being totally dependent upon staff for all ADL's (activities for daily living) (Id. at 47), including toileting (P. Ex. 14 at 1). Petitioner assessed the resident as having some control of her bladder and her care plan placed her in the toilet in advance of need (TIAN) program which required staff to offer toileting every two hours and as necessary, as well as checking her every two hours for incontinence. (CMS Ex. 13 at 49).

The surveyor alleged she observed Resident 27 for extended periods but the resident was not offered or assisted with toileting by staff. The surveyor made observations of Resident 27 on January 22, 2002, between 10:25 a.m. and 4:10 p.m. and she did not see the resident offered the opportunity to toilet as required by her care plan. CMS Ex. 19 at 30-32; Tr. 69-71.

Petitioner does not deny the accuracy of the surveyor's observations. Petitioner also presents no evidence to indicate that Resident 27 was, in fact, offered toileting. Petitioner has not rebutted that CMS prima facie showing as to Resident 27.

Based upon the foregoing, I conclude that Petitioner was in violation of 42 C.F.R. � 483.25(d)(2) (Tag F 316) with respect to both Resident 14 and Resident 27 as alleged by the surveyor. I also conclude that there was a potential for more than minimal harm due to the increased possibility for infections and skin breakdown and further decline as the surveyor testified.

8. Petitioner violated 42 C.F.R. � 483.25(h)(2) (Tag F 324).

This alleged deficiency also falls within the area of quality of care. The regulation requires, regarding the prevention of accidents, that a facility ensure that "(e)ach resident receives adequate supervision and assistance devices to prevent accidents." 42 C.F.R. � 483.25(h)(2). The specific manner by which facilities are to deliver care and services is not prescribed by the regulations. Rather, a facility is permitted to determine the means to achieve the regulatory ends. In the case of section 483.25(h)(2), the regulatory end is the prevention of accidental injury of nursing facility residents. The issue is whether the quality of the supervision or the use, or lack thereof, of assistance devices at Petitioner's facility was such that residents were subject to the risk of injury from accidental causes in their daily activities. In order to evaluate a facility's compliance with section 483.25(h), it is necessary to examine whether the facility did all it could to "prevent foreseeable accidents" or whether the facility did "everything in its power to prevent accidents." Odd Fellow and Rebekah Health Care Facility, DAB No. 1839, at 6-7 (2002), quoting Asbury Care Center at Johnson City, DAB No. 1815, at 12 (2002) and Koester Pavilion, DAB No. 1750, at 25-26 (2000). Section 483.25(h)(2) requires that a facility provide both "assistance devices" and "adequate supervision" to prevent accidents. What supervision or assistance devices are adequate depends on what kind of measures would be calculated to prevent potential accidents from occurring given the known or reasonably foreseeable risks. In Woodstock Care Center, the Board considered whether the facility had notice of or should reasonably have anticipated the risk of the kind of events that occurred and whether any reasonable means were available to prevent them without violating the residents' rights. DAB No. 1726, at 26-27 (2000). Based on the regulation and the cases in this area, CMS meets its burden to show a prima facie case if: (1) it presents evidence that an accident occurred (with or without harm to a resident); or (2) it shows the facility failed to do what it could to supervise residents or provide assistance devices to minimize risks that could lead to accidents.

The surveyors allege that Petitioner did not satisfy the regulatory requirement as to Resident 79, Resident 14, Resident 57, and Resident 42.

a. Resident 79

Petitioner objects to proceeding on the example related to Resident 79 because it was deleted during the first round of IDR and Petitioner was not notified that it was reinstated during the second round of IDR. Tr. 71-82; P. Brief at 16-17. CMS argued at the hearing (Tr. 72) and in post-hearing briefing (CMS Brief at 7) that Petitioner cannot argue surprise as documents indicating the CMS position that the example of Resident 79 was still being advanced by CMS were in the exchange of evidence and the position was also argued in the CMS prehearing brief. I deferred ruling at hearing, allowing CMS and Petitioner to present evidence in case I ultimately ruled for CMS.

In the copy of the SOD admitted as CMS Ex. 19 at page 32, there is a "DELETED" stamp over example 1 related to Resident 79 under tag F324. In the copy of the SOD admitted as P. Ex. 1 at page 27, the example related to Resident 79 has been deleted and the allegations as to Resident 14 are example 1. By letter dated March 8, 2002, the state agency advised Petitioner that as a result of IDR, a deficiency cited under Tag F 314 was deleted and that the proposed CMP was reduced from $600 per day to $450 per day. CMS Ex. 2. CMS Ex. 2 includes two other documents (CMS Ex. 2 at 3-4 and 6-7) ⁽⁷⁾ the first entitled "Informal Dispute Resolution" and the second "Phase 2 Informal Review Bureau of Regulatory Compliance." Petitioner's Administrator, Allison Matthews, agreed she received the two-page letter but denied receiving the two other documents included in CMS Ex. 2. Tr. 168-169. I find Ms. Matthews credible in this regard as the letter does not indicate that there were any enclosures and her testimony is undisputed on this point. I also note that the letter at CMS Ex. 2 is inaccurate or incomplete in reporting the results of IDR to the extent that the letter does not indicate that deficiencies cited under Tags F 166 and F 242 were also deleted after the second phase of IDR review. Compare CMS Ex. 2 at 1 with the table at CMS Ex. 2 at 6.

Out of an abundance of caution, I rule in favor of Petitioner and will not consider the example of Resident 79 cited as a violation of 42 C.F.R. � 483.25(h)(2). Notice is a fundamental element of our due process procedures. See e.g. Act � 1866(h); 42 C.F.R. � 488.434, 498.20. The evidence before me raises an issue of whether or not Petitioner was properly notified that the allegations regarding Resident 79 continued to be a basis for the imposition of an enforcement remedy. There is no question that CMS can pursue a deficiency even though it was deleted by IDR. NHC Healthcare-Moulton, DAB CR898 (2002); Palm Gardens of Gainesville, DAB CR1088 (2003). But that is not really the issue here as it appears that the example of Resident 79 was ultimately not deleted through the IDR process. The issue here is really the adequacy of the notice to Petitioner that it must defend this example. At first blush, Petitioner's claim of "surprise" appears to have no merit because there was indication of CMS's intent to proceed with the example in the evidence exchanged and in the CMS prehearing brief and because Petitioner appeared ready to defend as to Resident 79. However, the duty to give "reasonable notice" under section 1866(h) of the Act is upon the government. In this case, the issue was raised and CMS has not presented evidence that Petitioner received "reasonable notice" and Petitioner has not conceded it did. Due to the fundamental nature of the requirement for notice, the best remedy here is to simply not consider the example of Resident 79 cited as a violation of 42 C.F.R. � 483.25(h)(2). In this case, CMS has more than ample evidence of a violation based upon the remaining examples and the remedy I adopt is not unduly prejudicial to the interests of the government.

b. Resident 14

Resident 14 was assessed by Petitioner as being at risk for falls due to poor balance, unsteady gait, poor body control, her Parkinson's disease, poor eyesight, poor judgment, and impaired decision making skills. CMS Ex. 11 at 60, 65, 86, 88; P. Ex. 6. Records show that she was designated for the facility "Falling Star" program. CMS Ex. 11 at 31. On October 11, 2001, Resident 14 received a custom-made wheelchair, which was high strength, light weight, with an extra deep seat and anti-tippers and wheelchair extensions, and foam in the back to accommodate her kyphosis. CMS Ex. 11 at 83. There is no dispute that Resident 14's daughter wanted her to be able to sit outside unattended. Id. at 87. There is also no dispute that on November 16, 2001, Resident 14 went outside in her wheelchair, unattended and unsupervised. Resident 14 was found lying on her right side on the grass, the wheelchair having tipped over sideways. Tr. 189, 195-96; P. Ex. 6 at 1; CMS Ex. 11 at 91, 93. Resident 14 suffered a broken collar bone and an abrasion on her right shoulder and elbow. CMS Ex. 11 at 87, 91.

Petitioner argues that Resident 14 had given durable power of attorney to her daughter and the daughter had authority to make decisions regarding Resident 14's care and services. Petitioner argues that Resident 14's daughter resisted and refused interventions that might have reduced the risk of the resident falling and the daughter had insisted that Resident 14 be permitted to go outside. P. Brief at 18; P. Reply at 3-4. Petitioner also argued that it was not foreseeable that Resident 14 would take her wheelchair outside and roll off the edge of the porch or sidewalk causing her to fall over sideways. P. Reply at 3.

Resident 14 was known to be at risk for falls, to have poor balance, and to have bad judgment. Nevertheless, Petitioner allowed her to go outside the facility unsupervised. Petitioner's argument that it was not foreseeable that she would roll her wheelchair off the edge of the porch and tip over is not a defense. The question is not whether Petitioner could foresee the specific event; the question is whether it was foreseeable that a resident given Resident 14's impairments or limitations could be subject to harm if permitted to go outside unattended. The answer to that question is clearly yes - it was foreseeable that Resident 14 could be subject to harm if outside unattended. The risk of harm was obviously recognized by Petitioner because staff attempted to limit the resident's free access to outside, even though those attempts were rebuffed. The foreseeable risk of harm triggers the regulatory requirement that Petitioner implement adequate assistance devices and supervision to minimize the risk for harm. In this case, Petitioner provided no supervision to Resident 14 when she went outside on November 16, 2001, a clear violation of the regulation.

Petitioner's argument that the resident, or in this case her daughter, had the right to dictate care and services, is no defense to the violation in this case. There is no question that resident rights are protected under the regulations. However, a facility has to balance the need to protect the resident from harm and the resident's right to engage in certain behaviors. The fact that a resident may have a right to engage in behavior, including certain risky behaviors, does not relieve the facility of the duty to care for residents in their facility and to minimize the risk for harm to a resident or other residents. There needs to be a common sense balancing of the need to supervise a resident, the right to engage in risky behavior, and the resident's right to privacy or to reject treatment and care. See e.g. Tr. 186-88.

In this case, Petitioner did not supervise Resident 14 when she went outside in her wheelchair although it was clear to Petitioner that she required such supervision. Tr. 181-82. It is no defense that Resident 14's daughter insisted that Resident 14 be permitted to go outside, as Petitioner cannot simply avoid its duty to care for and protect a resident. Resident 14 suffered actual harm.

c. Resident 57

There is no dispute that Resident 57 had a history of multiple falls. Tr. 137; CMS Ex. 16; P. Ex. 7. On December 24, 2001, the resident was found on the floor beside his bed after his bed alarm sounded. P. Ex. 7 at 1. On January 5, 2002, Resident 57 fell when climbing out of bed, striking his buttocks. CMS Ex. 16 at 5; P. Ex. 7 at 2. Petitioner reacted by changing Resident 57's care plan to include the intervention of floor mats at the bedside and 30 minute checks on the resident. Tr. 286; CMS Ex. 16 at 5; P. Ex. 7 at 2. A surveyor observed Resident 57 during two days of the survey, January 22 and 24, 2002, in bed without floor mats on the floor beside the bed. Tr. 137, 145, 147; CMS Ex. 19 at 36. Petitioner's witness, Kimberly Parks, the Regional Director for Strategic Nursing Systems, testified that she worked with the administrator and administrative staff for Petitioner to deal with resident issues. She reviewed Resident 57's records and was at the facility during the survey. She testified that Resident 57 was in a low bed (Tr. 290) and that mats were used as an intervention but mostly at nighttime when he was more agitated rather than during the day. Tr. 284-87. It is not clear what records Ms. Parks reviewed, but they do not appear to be included in either CMS Ex. 16 or P. Ex. 7. Ms. Parks did not testify that she ever treated or cared for Resident 57 or that she was personally familiar with him other than based upon her records review. Ms Parks did not deny or rebut the surveyor's observation that Resident 57 was in bed without mats at his bedside.

Petitioner clearly recognized Resident 57's risk of falls and the possibility of injury as a result of a fall. Petitioner responded to Resident 57's risk for falling from bed by care planning for the intervention of floor mats by the bedside. Petitioner does not deny that Resident 57 was observed by the surveyor without floor mats at his bedside. I conclude Petitioner failed to provide assistance devices which it recognized were necessary. Petitioner care planned the use of floor mats and failed to implement that precaution consistently.

Petitioner's argument that the floor mats were primarily used in the evening when the resident was more active is simply not supported by credible evidence. Ms. Parks' basis for this knowledge has not been shown. Even if I accepted Ms. Parks' testimony as true, there is no explanation for why there was not a revised care plan to advise staff that mats were only necessary at certain times.

d. Resident 42

The surveyor alleged in the SOD that Resident 42 was observed on her mattress which was sliding out of her low bed and onto a floor mat beside the bed and her pressure sensitive alarm did not sound. CMS Ex. 19 at 36. The surveyor testified that both the resident and the mattress, which she believed was too small for the bed, were sliding off the bed frame and that is why the pressure sensitive alarm was not sounding. Tr. 138-139. The surveyor's testimony suggests that her concern was that the mattress was too small for the bed frame rather than that the interventions of the pressure sensitive alarm and the floor mat were not effective. CMS argues that Resident 42 fell out of bed because the facility failed to provide her a proper fitting mattress. CMS Brief at 11; CMS Reply at 15. Although CMS argues that there was the potential for harm to Resident 42, CMS and its witness never articulated what the potential harm was and it is not obvious given the facts that the resident was using a low bed with a floor mat and she had used the same mattress and bed for a year without reported incident. Tr. 288-89.

In order to make a prima facie showing of a violation of 42 C.F.R. � 483.25(h)(2), CMS must provide some evidence to show that there was either a failure to supervise or a failure to provide assistance devices creating a potential for harm. CMS has failed to make a prima facie showing of a violation concerning Resident 42.

9. Petitioner violated 42 C.F.R. � 483.75(f) (Tag F 498).

The administration standard is established by 42 C.F.R. � 483.75(f), which provides:

The facility must ensure that nurse aides are able to demonstrate competency in skills and techniques necessary to care for residents' needs, as identified through resident assessments, and described in the plan of care.

The surveyors allege that Petitioner did not satisfy this regulatory requirement as to Resident 27, Resident 14, Resident 26, Resident 78, and Resident 45. The examples cited by the surveyors allegedly show improper or unsafe resident transfers that may be attributed to the failure of the facility to ensure that nurses aides were able to demonstrate competency in the skills necessary to provide safe and proper resident transfers.

The surveyor alleged that Resident 27 was assessed by Petitioner to require extensive assistance of two or more persons for transfers and the care plan required two person assistance. The surveyor also alleged that facility policy required that any resident needing more than "contact guard assist" wear a gait belt while ambulating and for transfers. On January 22, 2002, the surveyor observed the resident transferred from chair to bed and then to a wheelchair without a gait belt and the resident was lifted under her arms and by pulling up on the back of her pants. CMS Ex. 19 at 37-38.

The surveyor alleged that Resident 14 had an order from her physician that she was not to be lifted under the right arm due to her collar bone fracture. On January 23, 2002, the surveyor saw two staff place a gait belt around the resident's waist but then lifted her under the arms to transfer her from her wheelchair to her bed, causing the resident to cry out that they were hurting her. Id. at 38. Petitioner's Director of Nursing, Ms. Campbell, agreed that it was not proper procedure for a nurse aide to place her arm under Resident 14's right arm but that Resident 14 often cried out when touched by staff. Tr. 266.

The surveyor alleged that Resident 26 was assessed by Petitioner as totally dependent upon staff and required a two or more person assist for transfers and the care plan provided for two or more person assist for transfers. On January 22, 2002, the surveyor saw the resident transferred from chair to bed. Staff applied a gait belt but lifted the resident under the arms. Id. at 39.

The surveyor alleged that Resident 78 was assessed as requiring two person assistance for transfers. On January 22, 2002, the surveyor saw the resident transferred from wheelchair to bed and back to the wheelchair. The wheels of the wheelchair were not locked and the wheelchair rolled during the transfer. Id.

The surveyor alleged that Resident 45 was assessed by Petitioner as being totally dependent on staff for transfers. On January 24, 2002, the surveyor saw the resident transferred from bed to a geri-chair. The wheels on the chair were not locked and the chair moved as the resident was lowered onto the chair. Id. at 40. Petitioner's witness, Ms. Parks, testified that she too observed the transfer to the geri-chair but it was placed against the wall when the transfer was done so it could not move. Tr. 290.

Surveyor Truett testified that transferring a resident by lifting them under their arms creates a risk for bone and soft tissue injuries. Tr. 87.

Petitioner does not deny the facts alleged by the surveyors except as I have noted. Petitioner does not deny that it had a policy requiring use of a gait belt for residents who needed assistance with transfers. Petitioner does not deny that a resident may experience soft tissue or bone injury by being lifted under the arms. Although Ms. Campbell disagreed that Resident 14 was actually lifted under the right arm by a staff member, she agrees that the staff member placed his hand in her right arm pit for some reason. Ms. Parks asserts that the geri-chair Resident 45 was being transferred to was against the wall and so could not move. However, the surveyor specifically saw the chair move when Resident 45 was lowered onto it. While Petitioner offers various explanations, none are legitimate defenses for failure to comply with safe transfer technique. Furthermore, the multiple examples cited indicate a general lack of training and competency among the staff in safe transfer practices.

10. A CMP of $450 per day is not reasonable, and it is therefore reduced to $250 per day.

Petitioner does not now challenge the reasonableness of the remedy, but rather argued exclusively that there was no basis for a remedy. In determining the amount of the CMP, the following factors specified at 42 C.F.R. � 488.438(f) must be considered:

(1) the facility's history of noncompliance;

(2) the facility's financial condition;

(3) the factors specified in 42 C.F.R. � 488.404 (The factors found at 42 C.F.R. � 488.404 include: (1) the scope and severity of the deficiency; (2) the relationship of the deficiency to other deficiencies resulting in noncompliance; and (3) the facility's prior history of noncompliance in general, specifically with reference to the cited deficiencies.); and

(4) the facility's degree of culpability, which includes neglect, indifference, or disregard for resident care, comfort, or safety. The absence of culpability is not a mitigating factor.

See 42 C.F.R. � 488.438(f).

After the IDR, CMS determined to impose a CMP of $450 per day for the period from January 25, 2002 through March 15, 2002, totaling $22,500. CMS based its determination to impose this CMP largely upon the actual harm that residents suffered from inadequate supervision and the failure to provide assistance devices under Tag F 324. The CMP that CMS imposed was also based on the existence of nine deficiencies. Of course, I found no violation of Tags F 274 and F 311, reducing the number of deficiencies to seven instead of nine. Further, I found that Tag F 324 was proved by two examples, concerning Resident 14 and Resident 57, not by the four examples CMS alleged. In addition, I determined that there was actual harm to only one resident, Resident 14. Therefore some adjustment to the amount of the CMP is appropriate.

I find that the actual harm suffered by Resident 14 by her fall, as discussed under Tag F 324, and the multiple examples cited under Tag F 498 showing the lack of training and competence of Petitioner's nurses aides, weigh heavily in my consideration. Petitioner was proven to have seven violations, one at an actual harm level, and six that present at least the potential for more than minimal harm. Petitioner also has some history of prior violations. CMS Ex. 8. I do not see evidence that there was significant culpability or willful neglect on Petitioner's part. The ability to pay does not appear to be an issue and was not addressed by Petitioner.

Petitioner has not advanced a claim that it came into compliance at a date earlier than March 15, 2002. Petitioner's position was that there were no deficiencies at all. Therefore, the only credible evidence I have of duration is the CMS determination on revisit survey that Petitioner achieved substantial compliance as of March 16, 2002, and that fact is not disputed before me.

I have considered what would be a reasonable CMP in this matter. I make my decision based on the factors cited at 42 C.F.R. �� 488.438(f) and 488.404 (incorporated by reference into 42 C.F.R. � 488.438(f)(3)). I have considered the Petitioner's history of noncompliance, Petitioner's financial condition, the seriousness of the deficiencies related to Resident 14, Petitioner's culpability for those deficiencies, and the fact that the number of deficiencies for which a CMP could be imposed were reduced from nine to seven. I conclude that a CMP of $250 per day for the period from January 25, 2002 through March 15, 2002, is reasonable. In determining the total number of days and penalty, I begin counting with January 26, 2002 (the first full day of noncompliance) and stop counting on March 15, 2002 (the facility was substantially compliant on March 16, 2002). See 42 C.F.R. � 488.440. The total number of days of noncompliance was 49 and the total CMP amounts to $12,250.

IV. CONCLUSION

For the foregoing reasons, I conclude that Petitioner failed to comply substantially with federal participation requirements and a CMP of $12,250 is reasonable.

Keith W. Sickendick

Administrative Law Judge

1. Citations are to the October 1, 2001 revision of Title 42 of the Code of Federal Regulations, which was in effect at the time of the survey, unless otherwise indicated.

2. The MDS is the document used for coding and transmitting RAI information to the state agency and/or CMS. State Operations Manual (SOM), App. P at P-29.

3. Petitioner is correct that the SOM was not promulgated by notice and comment ruling making and does not have the force and effect of a statute or regulation. P. Reply at 2. Nevertheless, the SOM does provide insight as to how the agency construes the statutes and regulations it is tasked to enforce. The SOM also establishes the procedures that CMS surveyors and state agency surveyors are directed to follow.

4. It is not necessary for this decision to address whether staff precautions are most appropriately placed in a resident's care plan.

5. Kyphosis is an abnormally increased convexity in the curvature of the thoracic spine that prevents one from maintaining an upright position.

6. Petitioner indicates in its post hearing brief that Surveyor Truett "was permitted to testify regarding R#68" over Petitioner's objection. P. Brief at 11. This is an inaccurate representation of my ruling on Petitioner's objection at hearing. CMS did not offer the testimony of Surveyor Bewanger, who made the allegations in the SOD related to Resident 68. Petitioner objected when CMS attempted to elicit testimony from Surveyor Truett about the findings and allegations related to Resident 68. Tr. 42. I specifically ruled that I would not allow Surveyor Truett to testify regarding Resident 68. Tr. 44. It is clear that Ms. Truett had no knowledge regarding Resident 68 separate from her reading of the documents admitted in evidence without objection by Petitioner, specifically CMS Exs. 17 and 19. It was unnecessary for Ms. Truett to testify regarding her opinion of the meaning and weight of the documentary evidence and would have invaded my province as the finder of fact. However, I did allow CMS to elicit opinions from Ms. Truett in her capacity as a nurse and surveyor, over Petitioner's objections (Tr. 44, 59) regarding facts CMS gleaned from the documentary evidence that was admitted without objection. On review of the transcript, I conclude that it was proper to allow Ms. Truett to opine, particularly in her capacity as an experienced surveyor. However, I find her opinions not helpful in resolution of the deficiency related to Resident 68.

7. CMS Ex. 2 was incorrectly marked and there is no page 5.